IRIS : Use of Implantable Defibrillator in High-Risk Patients Early After Acute Myocardial Infarction
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ClinicalTrials.gov Identifier: NCT00157768
Verified August 2008 by Medtronic Bakken Research Center. Recruitment status was: Active, not recruiting
Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. The prognosis appears not improved by medication with antiarrhythmics (class I/III). A positive effect of beta-blockers (Metoprolol CR/Zok) on total mortality after myocardial infarction in patients with heart failure is well established. On the other hand, an implantable defibrillator (ICD) proved to be superior to medication when used for secondary prevention in patients after cardiac arrest. The question arises whether ICD therapy is also effective in primary prevention in high risk patients after acute myocardial infarction. This study determines if patients, who were defined as high risk patients in the early post infarction phase by means of noninvasive methods, benefit from primary prevention by means of an ICD. Special emphasis is put on an individual optimization of the infarction therapy, including beta-blockers.
The null hypothesis is that all cause mortality in the treatment (Implantable cardioverter defibrillator =ICD) and control group is identical. The alternative hypothesis is that all cause mortality in the ICD group and control group is different.
Secondary Outcome Measures
Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,
Device-related complications, Hospitalizations, Quality of life
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
acute myocardial infarction (5-31 days)
fulfill requirement I and/or II :
I first ECG heart rate >= 90 bpm (within day 1-2 post MI) and LVEF <= 40 % (within day 5-31 post-MI)
II >= 1 episode of non-sustained ventricular tachycardia >= 150 bpm (on Holter, within 5-31 days post-MI)
Patients with ventricular arrhythmia, requiring clinical therapy, before the index infarction or more than 48 h later
Patients with therapy refractory heart failure (NYHA IV)
Myocardial infarction older than 31 days
First-ECG not available or was recorded more than 48 h after the symptom onset.
Patients with indication for CABG operation before inclusion
Patients with cerebral organic psycho syndrome
Secondary diseases which clearly limit life expectancy